Eligibility criteria illustrate the characteristics of the study population and promote the safety of participants. However, overreliance on restrictive eligibility criteria may limit the generalizability of outcomes. As a result, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) issued statements to curtail these challenges. In this study, we aimed to assess restrictiveness in eligibility criteria across advanced prostate cancer clinical trials.
We identified all phase I, II, and III advanced prostate cancer clinical trials between June 30, 2012, and June 30, 2022, through Clinicaltrials.gov. We evaluated whether a clinical trial excluded, conditionally included, or did not report 4 common criteria: brain metastases, prior or concurrent malignancies, HIV infection, and hepatitis B virus (HBV)/hepatitis C virus (HCV) infection. Performance status (PS) criteria were recorded based on the Eastern Cooperative Oncology Group (ECOG) scale.
Out of 699 clinical trials within our search strategy, 265 (37.9%) trials possessed all the required data and were included in our analysis. The most common excluded condition of our interest was brain metastases (60.8%), followed by HIV positivity (46.4%), HBV/HCV positivity (46.0%), and concurrent malignancies (15.5%). Additionally, 50.9% of clinical trials only included patients with ECOG PS 0 to 1. HIV and HBV/HCV infection were exclusion criteria of 22 (80.8%) and 19 (73.1%) immunotherapy trials, respectively.
Patients with brain metastases, prior or concurrent malignancies, HIV infection, HBV/HCV infection, or low-functioning PS were overly restricted from participating in advanced prostate clinical trials. Advocating for broader criteria may ameliorate generalizability.
Clinical genitourinary cancer. 2023 May 24 [Epub ahead of print]
Hedyeh Ebrahimi, Daniela V Castro, Matthew I Feng, Sweta R Prajapati, Kyle O Lee, Elyse H Chan, Trishita Paul, Ishaan Sehgal, Jalen Patel, Xiaochan Li, Zeynep B Zengin, Luis Meza, Benjamin D Mercier, JoAnn Hsu, Ameish Govindarajan, Neal Chawla, Nazli Dizman, Cristiane D Bergerot, Adam Rock, Sandy Liu, Abhishek Tripathi, Tanya Dorff, Sumanta K Pal, Alexander Chehrazi-Raffle
Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA., Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA; Department of Internal Medicine, Yale University School of Medicine, Yale New Haven Hospital, New Haven, CT., Centro de Câncer de Brasília (CETTRO), Instituto Unity de Ensino e Pesquisa, Brasília, Brazil., Department of Medical Oncology, City of Hope Orange County Medical Center, Irvine, CA., Department of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA. Electronic address: .